Victor Boatright
Quality Engineer @Gilero, A Sanner Group Company
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WORK HISTORY
Quality Engineer @Gilero, A Sanner Group Company
Durham, NC, US
Represent the quality function in product development projects providing support for development and commercialization activities. Author design history file documents during the development process.* Translate user input into measurable product requirements and specifications.* Support design verification and validation activities including authoring test protocols and reports.* Ensure compliant project documentation provides clear status and traceability in alignment with good documentation practice and controls hierarchy.* Manage, trend, and continuously improve assigned quality system element (CAPA, Complaints, Supplier Management, External Audits, etc.)* Participate in risk analysis assessments of medical devices.* Maintain accurate and complete Design History Files, including regulatory submission documents.* Assist with manufacturing transfer, including preparation and execution of process validation (IQ,/OQ/PQ) protocols, and development of production inspection plans.* Investigate, disposition, and resolve nonconforming material events during product development, pre-production, and production phases.* Author new or revised procedures, train team members and release quality system procedures, as required.* Support internal and external audits.* Support supplier selection, qualification, and on-going monitoring.* Facilitate investigations to determine root cause and failure modes.* Maintain quality records, summarize data, and report quality metrics to the organization.* Execute quality event initiation, investigation, and closure for nonconformance, CAPA, change control and complaints. Perform effectiveness checks.* Proficient with FDA 820 CFRs/ISO 13485/cGMP quality management systems and requirements for medical device and combination product development and manufacturing.* Perform risk analysis and continuous improvement concepts.
EDUCATION
Micro Tech Training Center, Inc.
PC Applications Specialist, Certificate of Training
East Carolina University
Master of Science Technology Management, Quality Systems concentration
Monmouth County Vocational School District
Certificate of Training, Automobile/Automotive Mechanics Technology/Technician
Wilson Community College
Associate of Arts and Sciences (A.A.S.), Mechanical Engineering Technology
Wilson Community College
Certificate, Computer Aided Design
East Carolina University
Bachelor's, Industrial Technology - Manufacturing Systems concentration
ABOUT VICTOR BOATRIGHT
Solutions-oriented, Certified Quality Engineer (CQE) & Six Sigma Green Belt dedicated to leveraging strong training and experience to increase production standards within high growth organizations and achieve corporate vision for growth.
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